The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Product Models: See Medical Device Recall Database entry Distribution Dates: March 6,…
An Ounce of Prevention Is Worth A Pound Of Cure
Image Español The bad news: Heartworm disease can be fatal to dogs, cats, and ferrets. The good news: You can protect your pet from this disease. An ounce of prevention is worth a pound of cure Heartworms can infect your pet year-round and preventing them is much easier, and healthier, for your pet than getting heartworms…
FDA D.I.S.C.O. Burst Edition: FDA approvals of Tecentriq (atezolizumab) for unresectable or metastatic alveolar soft part sarcoma, and Krazati (adagrasib) for KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on two recent FDA cancer drug approvals. On December 9, 2022, the FDA approved atezolizumab (brand name…
FDA D.I.S.C.O. Burst Edition: FDA approval of Adstiladrin (nadofaragene firadenovec-vncg) for patients with high-risk Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer therapeutic approval. On December 16, 2022, the FDA approved nadofaragene firadenovec-vncg (brand…
FDA D.I.S.C.O. Burst Edition: FDA approval of Lunsumio (mosunetuzumab-axgb) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval. On December 22, 2022, the FDA granted accelerated approval to…
FDA D.I.S.C.O. Burst Edition: FDA approves updated drug labeling including new indications and dosing regimens for Xeloda (capecitabine) tablets under Project Renewal
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval. On December 14, 2022, the FDA approved updated labeling for…
Allergic to Sesame? Food Labels Now Must List Sesame as an Allergen
[embedded content] If you or someone in your household is allergic to sesame, an important change is taking place to help you quickly identify foods that contain sesame. As of January 1, 2023, sesame is required to be labeled as an allergen on packaged foods, including dietary supplements. Sesame joins eight other foods already declared…
FDA D.I.S.C.O. Burst Edition: FDA approval of Rezlidhia (olutasidenib) for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide another quick update on a recent FDA cancer drug approval. On December 1, 2022, the FDA approved olutasidenib (brand name…
Spectrum Laboratory Products, Inc. Issues Voluntary Worldwide Recall of Epinephrine (L-Adrenaline) USP Bulk Active Pharmaceutical Ingredient (API) Due to Discoloration of Product
Summary Company Announcement Date: January 09, 2023 FDA Publish Date: January 09, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Product discoloration Company Name: Spectrum Laboratory Products Inc. Brand Name: Brand Name(s) Product Description: Product Description Epinephrine bulk API Company Announcement Spectrum Laboratory Products, Inc. is voluntarily recalling three lots of Epinephrine (L-Adrenaline)…
FDA D.I.S.C.O. Burst Edition: FDA approval of Elahere (mirvetuximab soravtansine-gynx) for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval. On November 14, 2022, the FDA granted accelerated approval to…